Effect of Food on the Pharmacokinetics of XZP-3287 in Healthy Subjects

Healthy Clinical Trial

Official title:

A Phase I Study to Examine the Effects of Low and High-fat Meals on Orally Administered XZP-3287 in Healthy Adult Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04951765
• Other study ID #: XZP-3287-1002
• Status: Recruiting
• Phase: Phase 1
• Start date: August 2021
• Est. completion date: December 2021

Study information

• Verified date: June 2021
• Source: Xuanzhu Biopharmaceutical Co., Ltd.
• Contact: Cuilan Xiao
• Phone: 0086-13699167610
• Email: xiaocuilan[@]xuanzhubio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will be a randomized 3-treatment, cross-over study to evaluate the bioavailability of XZP-3287 administered after a high or low-fat meal.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Inclusion Criteria

1. Healthy male or female subjects aged 18 to 65 years (including 18 and 65);

2. Male body weight =50kg, female body weight =45kg, body mass index between 18 to 28 kg/m2 (inclusive).

3. No medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.

4. Subjects shall ake effective contraceptive measures voluntarily within 3 months from the date of signing the informed consent form (for women, 2 weeks before trial screening) to the date of the last medication.

5. Willing and able to comply with all scheduled visits, study procedures, and provides written informed consent

Exclusion Criteria:

1. Allergic constitution and those with known allergy to XZP-3287 or similar drugs and excipients

2. Abnormal clinical tests and clinical significance judged by the investigator

3. Frequent use of sedatives, sleeping pills or other addictive drugs within 6 months before enrollment

4. History of drug use, or drug abuse screening positive

5. Those who had smoked more than 5 cigarettes per day on average in the 3 months before the screening period or habitually used nicotine-containing products and were unable to quit during the test period

6. Heavy drinking or regular drinking in the six months preceding the screening period

7. Use of any prescription drug or Chinese herbal medicine within 4 weeks prior to enrollment, or use of any over-the-counter drug, any vitamin product, health care drug within 14 days prior to enrollment;

8. Treatment with an investigational drug within 3 months

9. Participated in blood donation with blood donation volume =400 mL or received blood transfusion within 3 months before screening.

10. Had a severe infection, trauma or major surgery within 4 weeks of screening

11. Gastrointestinal disorders causing clinically significant symptoms such as nausea, vomiting, and diarrhea, or malabsorption syndromes

12. Pregnant or lactating women, or subjects cannot take strict contraceptive measures as required.

13. Hepatitis B surface antigen or E antigen, hepatitis C antibody, HIV antibody and syphilis antibody, any of which are positive.

14. Allergic to any food ingredients or has special requirements on diet, cannot follow the unified diet

15. habitual consumption of food or beverage containing methylxanthine, such as tea, coffee, cola, chocolate and so on during the study period

16. habitual consumption of grapefruit juice during the study period

17. have difficulty in blood collection or cannot tolerate vein puncture for blood collection

18. As determined by the investigator, the subject has other factors that are not suitable for the study -

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• XZP-3287
Cycle1 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle2 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast
• XZP-3287
Cycle1 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle2 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 before starting a low-fat breakfast
• XZP-3287
Cycle1 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle2 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast
• XZP-3287
Cycle1 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle2 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast
• XZP-3287
Cycle1 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle2 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast
• XZP-3287
Cycle1 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle2 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle3 Day 1: one dose of XZP-3287 before starting a low-fat breakfast

Locations

Country	Name	City	State
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Xuanzhu Biopharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary PK Endpoints	Cmax	day 1~day 21
Primary	Primary PK Endpoints	AUC0-8	day 1~day 21
Primary	Primary PK Endpoints	AUC0-t	day 1~day 21
Secondary	Secondary PK measures	Tmax	day 1~day 21
Secondary	Secondary PK measures	T1/2	day 1~day 21
Secondary	Secondary PK measures	CL/F	day 1~day 21
Secondary	Secondary PK measures	Vz/F	day 1~day 21
Secondary	Safety and tolerability	Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE 5.0	Up to 14 days after last dose